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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00077766




Registration number
NCT00077766
Ethics application status
Date submitted
12/02/2004
Date registered
16/02/2004
Date last updated
26/10/2016

Titles & IDs
Public title
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Scientific title
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Secondary ID [1] 0 0
BA17283
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]

Experimental: RO0503821 (1x/2 Weeks) - Eligible participants will be administered with RO0503821 ([methoxy polyethylene glycol-epoetin beta] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).

Active Comparator: Darbepoetin (1x/1-2 Weeks) - Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.


Treatment: Drugs: Darbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period - A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.
Timepoint [1] 0 0
Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
Secondary outcome [1] 0 0
Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration - The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.
Timepoint [1] 0 0
Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
Secondary outcome [2] 0 0
Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods - A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).
Timepoint [2] 0 0
Week 1 to Week 36
Secondary outcome [3] 0 0
Number of Participants With Marked Laboratory Abnormalities - A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/liter [L]), platelets (100 - 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 - Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).
Timepoint [4] 0 0
Baseline, Week 36, and Week 52
Secondary outcome [5] 0 0
Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 - Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.
Timepoint [5] 0 0
Baseline, Week 36, and Week 52
Secondary outcome [6] 0 0
Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths - An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
Timepoint [6] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
- adult patients >=18 years of age;

- chronic renal anemia;

- on dialysis therapy for at least 12 weeks before screening;

- receiving darbepoetin alfa iv for at least 8 weeks before screening.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;

- administration of another investigational drug within 4 weeks before screening, or
during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Blacktown
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Gosford
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
NSW 2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
1871 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Aalst
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Manitoba
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Denmark
State/province [10] 0 0
Aalborg
Country [11] 0 0
Denmark
State/province [11] 0 0
Odense
Country [12] 0 0
Denmark
State/province [12] 0 0
Roskilde
Country [13] 0 0
Finland
State/province [13] 0 0
HUS
Country [14] 0 0
France
State/province [14] 0 0
Aubervilliers
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Nice
Country [17] 0 0
France
State/province [17] 0 0
Strasbourg
Country [18] 0 0
France
State/province [18] 0 0
Tarbes
Country [19] 0 0
France
State/province [19] 0 0
Toulouse
Country [20] 0 0
Germany
State/province [20] 0 0
Hann. Münden
Country [21] 0 0
Germany
State/province [21] 0 0
Nürnberg
Country [22] 0 0
Germany
State/province [22] 0 0
Villingen-schwenningen
Country [23] 0 0
Italy
State/province [23] 0 0
Bergamo
Country [24] 0 0
Italy
State/province [24] 0 0
Lecco
Country [25] 0 0
Italy
State/province [25] 0 0
Livorno
Country [26] 0 0
Italy
State/province [26] 0 0
Messina
Country [27] 0 0
Italy
State/province [27] 0 0
Pavia
Country [28] 0 0
Spain
State/province [28] 0 0
Badalona
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Córdoba
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Oviedo
Country [33] 0 0
Spain
State/province [33] 0 0
Salamanca
Country [34] 0 0
Spain
State/province [34] 0 0
Santander
Country [35] 0 0
Sweden
State/province [35] 0 0
Karlstad
Country [36] 0 0
Sweden
State/province [36] 0 0
Stockholm
Country [37] 0 0
Switzerland
State/province [37] 0 0
Aarau
Country [38] 0 0
Switzerland
State/province [38] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as
maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who
were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2
years and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00077766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications